Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial

Sang Hoon Na; Hae Young Lee; Sang Hong Baek; Hui Kyung Jeon; Jin Ho Kang; Yoon Nyun Kim; Chang Gyu Park; Jae Kean Ryu; Moo Yong Rhee; Moo Hyun Kim; Taek Jong Hong; Dong Ju Choi; Seong Wook Cho; Dong Hun Cha; Eun Seok Jeon; Jae Joong Kim; Joon Han Shin; Sung Ha Park; Seung Hwan Lee; Sung Hee John; Eun Seok Shin; Nam Ho Kim; Sung Yun Lee; Jun Kwan; Myung Ho Jeong; Sang Wook Kim; Jin Ok Jeong; Dong Woon Kim; Nam Ho Lee; Woo Jung Park; Jeong Cheon Ahn; Kyung Heon Won; Seung Uk Lee; Jang Hyun Cho; Soon Kil Kim; Taehoon Ahn; Sukkeun Hong; Sang Yong Yoo; Song Yi Kim; Byung Soo Kim; Jae Hyeon Juhn; Sun Young Kim; Yu Jeong Lee; Byung Hee Oh

doi:10.1016/j.clinthera.2015.05.512

Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial

Sang Hoon Na, Hae Young Lee, Sang Hong Baek, Hui Kyung Jeon, Jin Ho Kang, Yoon Nyun Kim, Chang Gyu Park, Jae Kean Ryu, Moo Yong Rhee, Moo Hyun Kim, Taek Jong Hong, Dong Ju Choi, Seong Wook Cho, Dong Hun Cha, Eun Seok Jeon, Jae Joong Kim, Joon Han Shin, Sung Ha Park, Seung Hwan Lee, Sung Hee JohnEun Seok Shin, Nam Ho Kim, Sung Yun Lee, Jun Kwan, Myung Ho Jeong, Sang Wook Kim, Jin Ok Jeong, Dong Woon Kim, Nam Ho Lee, Woo Jung Park, Jeong Cheon Ahn, Kyung Heon Won, Seung Uk Lee, Jang Hyun Cho, Soon Kil Kim, Taehoon Ahn, Sukkeun Hong, Sang Yong Yoo, Song Yi Kim, Byung Soo Kim, Jae Hyeon Juhn, Sun Young Kim, Yu Jeong Lee, Byung Hee Oh

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Purpose The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension. Methods Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ¥.

Original language	English
Pages (from-to)	1726-1739
Number of pages	14
Journal	Clinical Therapeutics
Volume	37
Issue number	8
DOIs	https://doi.org/10.1016/j.clinthera.2015.05.512
Publication status	Published - 2015 Aug 1

Bibliographical note

Funding Information:
Drs. BH Oh and HY Lee made substantial contributions to the study design, Drs. SH Na, BH Oh, and HY Lee were contributed in the manuscript writing, figure creation. All the authors were equally contributed in the data collection, data interpretation, literature serach, and were involved in all stages of manuscript development. This study was sponsored by LG Life Sciences, Ltd, Seoul, Korea. The sponsor supported the supply of the investigational products, laboratory test, and clinical research coordinator expenses.

Publisher Copyright:
© 2015 ElsevierHSJournals,Inc.Allrightsreserved.

All Science Journal Classification (ASJC) codes

Pharmacology
Pharmacology (medical)

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Na, S. H., Lee, H. Y., Hong Baek, S., Jeon, H. K., Kang, J. H., Kim, Y. N., Park, C. G., Ryu, J. K., Rhee, M. Y., Kim, M. H., Hong, T. J., Choi, D. J., Cho, S. W., Cha, D. H., Jeon, E. S., Kim, J. J., Shin, J. H., Park, S. H., Lee, S. H., ... Oh, B. H. (2015). Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial. Clinical Therapeutics, 37(8), 1726-1739. https://doi.org/10.1016/j.clinthera.2015.05.512

Na, Sang Hoon ; Lee, Hae Young ; Hong Baek, Sang et al. / Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy : A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial. In: Clinical Therapeutics. 2015 ; Vol. 37, No. 8. pp. 1726-1739.

@article{d5c10f6117c9454fad1419e2a12eb1ce,

title = "Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial",

abstract = "Purpose The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension. Methods Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ¥.",

author = "Na, {Sang Hoon} and Lee, {Hae Young} and {Hong Baek}, Sang and Jeon, {Hui Kyung} and Kang, {Jin Ho} and Kim, {Yoon Nyun} and Park, {Chang Gyu} and Ryu, {Jae Kean} and Rhee, {Moo Yong} and Kim, {Moo Hyun} and Hong, {Taek Jong} and Choi, {Dong Ju} and Cho, {Seong Wook} and Cha, {Dong Hun} and Jeon, {Eun Seok} and Kim, {Jae Joong} and Shin, {Joon Han} and Park, {Sung Ha} and Lee, {Seung Hwan} and John, {Sung Hee} and Shin, {Eun Seok} and Kim, {Nam Ho} and Lee, {Sung Yun} and Jun Kwan and Jeong, {Myung Ho} and Kim, {Sang Wook} and Jeong, {Jin Ok} and Kim, {Dong Woon} and Lee, {Nam Ho} and Park, {Woo Jung} and Ahn, {Jeong Cheon} and Won, {Kyung Heon} and {Uk Lee}, Seung and Cho, {Jang Hyun} and Kim, {Soon Kil} and Taehoon Ahn and Sukkeun Hong and Yoo, {Sang Yong} and Kim, {Song Yi} and Kim, {Byung Soo} and Juhn, {Jae Hyeon} and Kim, {Sun Young} and Lee, {Yu Jeong} and Oh, {Byung Hee}",

note = "Funding Information: Drs. BH Oh and HY Lee made substantial contributions to the study design, Drs. SH Na, BH Oh, and HY Lee were contributed in the manuscript writing, figure creation. All the authors were equally contributed in the data collection, data interpretation, literature serach, and were involved in all stages of manuscript development. This study was sponsored by LG Life Sciences, Ltd, Seoul, Korea. The sponsor supported the supply of the investigational products, laboratory test, and clinical research coordinator expenses. Publisher Copyright: {\textcopyright} 2015 ElsevierHSJournals,Inc.Allrightsreserved.",

year = "2015",

month = aug,

day = "1",

doi = "10.1016/j.clinthera.2015.05.512",

language = "English",

volume = "37",

pages = "1726--1739",

journal = "Clinical Therapeutics",

issn = "0149-2918",

publisher = "Excerpta Medica",

number = "8",

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Na, SH, Lee, HY, Hong Baek, S, Jeon, HK, Kang, JH, Kim, YN, Park, CG, Ryu, JK, Rhee, MY, Kim, MH, Hong, TJ, Choi, DJ, Cho, SW, Cha, DH, Jeon, ES, Kim, JJ, Shin, JH, Park, SH , Lee, SH, John, SH, Shin, ES, Kim, NH, Lee, SY, Kwan, J, Jeong, MH, Kim, SW, Jeong, JO, Kim, DW, Lee, NH, Park, WJ, Ahn, JC, Won, KH, Uk Lee, S, Cho, JH, Kim, SK, Ahn, T, Hong, S, Yoo, SY, Kim, SY, Kim, BS, Juhn, JH, Kim, SY, Lee, YJ & Oh, BH 2015, 'Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial', Clinical Therapeutics, vol. 37, no. 8, pp. 1726-1739. https://doi.org/10.1016/j.clinthera.2015.05.512

Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial. / Na, Sang Hoon; Lee, Hae Young; Hong Baek, Sang et al.
In: Clinical Therapeutics, Vol. 37, No. 8, 01.08.2015, p. 1726-1739.

Research output: Contribution to journal › Article › peer-review

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T2 - A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial

AU - Na, Sang Hoon

AU - Lee, Hae Young

AU - Hong Baek, Sang

AU - Jeon, Hui Kyung

AU - Kang, Jin Ho

AU - Kim, Yoon Nyun

AU - Park, Chang Gyu

AU - Ryu, Jae Kean

AU - Rhee, Moo Yong

AU - Kim, Moo Hyun

AU - Hong, Taek Jong

AU - Choi, Dong Ju

AU - Cho, Seong Wook

AU - Cha, Dong Hun

AU - Jeon, Eun Seok

AU - Kim, Jae Joong

AU - Shin, Joon Han

AU - Park, Sung Ha

AU - Lee, Seung Hwan

AU - John, Sung Hee

AU - Shin, Eun Seok

AU - Kim, Nam Ho

AU - Lee, Sung Yun

AU - Kwan, Jun

AU - Jeong, Myung Ho

AU - Kim, Sang Wook

AU - Jeong, Jin Ok

AU - Kim, Dong Woon

AU - Lee, Nam Ho

AU - Park, Woo Jung

AU - Ahn, Jeong Cheon

AU - Won, Kyung Heon

AU - Uk Lee, Seung

AU - Cho, Jang Hyun

AU - Kim, Soon Kil

AU - Ahn, Taehoon

AU - Hong, Sukkeun

AU - Yoo, Sang Yong

AU - Kim, Song Yi

AU - Kim, Byung Soo

AU - Juhn, Jae Hyeon

AU - Kim, Sun Young

AU - Lee, Yu Jeong

AU - Oh, Byung Hee

N1 - Funding Information: Drs. BH Oh and HY Lee made substantial contributions to the study design, Drs. SH Na, BH Oh, and HY Lee were contributed in the manuscript writing, figure creation. All the authors were equally contributed in the data collection, data interpretation, literature serach, and were involved in all stages of manuscript development. This study was sponsored by LG Life Sciences, Ltd, Seoul, Korea. The sponsor supported the supply of the investigational products, laboratory test, and clinical research coordinator expenses. Publisher Copyright: © 2015 ElsevierHSJournals,Inc.Allrightsreserved.

PY - 2015/8/1

Y1 - 2015/8/1

N2 - Purpose The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension. Methods Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ¥.

AB - Purpose The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension. Methods Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ¥.

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Na SH, Lee HY, Hong Baek S, Jeon HK, Kang JH, Kim YN et al. Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial. Clinical Therapeutics. 2015 Aug 1;37(8):1726-1739. doi: 10.1016/j.clinthera.2015.05.512

Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial

Abstract

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